FDA Label for Chloraprep Swabstick

Active Ingredients

Chlorhexidine gluconate (CHG), 2% w/v

and Isopropyl alcohol (IPA), 70% v/v

Purpose

Antiseptic

Use

for the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.

for the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.

Warnings

For external use only. Flammable, keep away from fire or flame.

• do not use with electrocautery procedures

Allergy Alert:

This product may cause a severe allergic reaction.

Symptoms may include:

• wheezing/difficulty breathing
• shock
• facial swelling
• hives
• rash

If an allergic reaction occurs, stop use and seek medical help right away.

Do Not Use

• on patients allergic to chlorhexidine gluconate or any other ingredient in this product
• for lumbar puncture or in contact with the meninges
• on open skin wounds or as a general skin cleanser

When Using This Product,

keep out of eyes, ears, and mouth. May cause serious or permanent injury if permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor.

Stop Use And Ask A Doctor If

irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
• maximal treatment area using
• one single swabstick applicator is approximately 2.5 in. x 2.5 in. (42 cm ²)
• three swabsticks sequentially is approximately 5 in. x 5 in. (160 cm ²)
• tear pouch at side notch to reveal applicator handles. Do not touch foam applicator tip. Place foam flat side down on the treatment area.
• completely wet the treatment area with antiseptic
• dry surgical sites (e.g., abdomen or arm): use repeated back-and-forth strokes for 30 seconds. (When using the triple swabstick applicators, use each swabstick sequentially within the 30 seconds). Allow the area to air dry for approximately 30 seconds. Do not blot or wipe away.
• moist surgical sites (e.g., inguinal fold): use repeated back-and-forth strokes for 2 minutes. (When using the triple swabstick applicators, use each swabstick sequentially within the 2 minutes). Allow the area to air dry for approximately 1 minute. Do not blot or wipe away.
• discard the applicator after a single use along with any portion of the solution not required to cover the prep area. It is not necessary to use the entire amount available.

Other Information

• store between 15-30 °C (59-86 °F)
• avoid freezing and excessive heat above 40 °C (104 °F)

Inactive Ingredient

• USP purified water

Questions?

• www.chloraprep.com
• call 1-800-523-0502 (M-F 8 a.m.-5 p.m. CST)

Package/Label Principal Display Panel

54365-401-28 - 6 930150 IntCtn Rev B Single Swab US clean

PRINCIPAL DISPLAY PANEL-CARTON

BD ChloraPrep™ Single Swabstick

Chlorhexidine gluconate (CHG), 2% w/v

and Isopropyl alcohol (IPA), 70% v/v Swab

Patient Preoperative Skin Preparation

Sterile Solution

Applicator is sterile if package is intact

1.75 mL Applicators

NDC 054365-401-28

Ref 930100

PRINCIPAL DISPLAY PANEL-CARTON

BD ChloraPrep™ Triple Swabstick

Chlorhexidine gluconate (CHG), 2% w/v

and Isopropyl alcohol (IPA), 70% v/v Swab

Patient Preoperative Skin Preparation

Sterile Solution

Applicator is sterile if package is intact

5.25 mL Applicators

NDC 054365-401-29

Ref 930103